Surgical stapling device with elongated tool assembly and methods of use

ABSTRACT

A surgical stapling device includes an elongated tool assembly having spaced first and second jaws positioned to receive a body organ. The length of the tool assembly (which may have a curved configuration) is selected to receive and staple and/or transect a body organ in a single actuation of the tool assembly.

BACKGROUND 1. Technical Description

The present disclosure is directed to surgical stapling devices, andmore particularly, to surgical stapling devices that include elongatedtool assemblies dimensioned to perform transection of body organs in asingle actuation of the tool assembly.

2. Background of Related Art

During surgical procedures such as gastric sleeve procedures, i.e.,sleeve gastrectomy procedures, a portion of a body organ, e.g., thestomach is divided and/or removed using a surgical stapling devicehaving a knife. Typically, the surgical stapling device includes a toolassembly that has a length that is shorter than the length of theportion of the body organ being transected. As such, the surgicalstapling device must be actuated multiple times to provide a staple/cutline that extends entirely across the body organ. To avoid creating astaple line that is susceptible to leakage, the clinician must properlyalign the stapling device with an existing portion of the staple/cutline during each actuation of the surgical stapling device to form acontinuous staple line along the cut line.

It would be desirable to provide a surgical stapling device capable oftransecting a body organ such as the stomach more quickly whileminimizing the potential for leakage along the staple line.

SUMMARY

In one aspect of the present disclosure, a surgical stapling deviceincludes an actuator including a housing defining a handle assembly, anadaptor assembly having a proximal portion releasably secured to theactuator and a distal portion. A tool assembly is supported on thedistal portion of the adaptor assembly and includes a first jaw and asecond jaw. The first jaw is movable in relation to the second jaw froman unclamped position to a clamped position. The first jaw is secured tothe second jaw by distal and proximal approximation shafts. The distaland proximal approximation shafts are configured to effect parallelclosure of the first and second jaws of the tool assembly. In theunclamped position, the distal approximation shaft is secured to adistal portion of the first jaw and a distal portion of the second jawto secure the distal portion of the first jaw of the tool assembly tothe distal portion of the second jaw, and the proximal approximationshaft is secured to a proximal portion of the first jaw and a proximalportion of the second jaw to secure the proximal portion of the firstjaw to the proximal portion of the second jaw.

In some embodiments, the first jaw supports an anvil and the second jawsupports a cartridge assembly.

In certain embodiments, the cartridge assembly includes a staplecartridge having a plurality of staples.

In embodiments, the cartridge assembly includes an anvil drive screwthat is operably engaged with the distal and proximal approximationshafts and is actuable via the actuator to effect parallel closure ofthe first and second jaws of the tool assembly.

In some embodiments, the cartridge assembly includes a sled that issupported within the staple cartridge and movable from a retractedposition to an advanced position to eject the plurality of staples fromthe staple cartridge.

In certain embodiments, the cartridge assembly includes a sled drivescrew that is operably engaged with the sled to move the sled from theretracted position to the advanced position.

In embodiments, the tool assembly defines a radius of curvature ofbetween 15 cm and 35 cm.

In some embodiments, the tool assembly has a length of between 27 cm and34 cm.

In certain embodiments, the tool assembly has a length of between 8 cmand 10 cm.

In embodiments, the tool assembly has a length of between 6 cm and 8 cm.

In some embodiments, the proximal approximation shaft includes a pair ofproximal approximation shafts and the distal approximation shaftincludes a pair of distal approximation shafts.

In certain embodiments, each of the proximal and distal approximationshafts includes a threaded shaft rotatably supported on the first jawand axially fixed to the first jaw, and the second jaw defines athreaded bore that receives each of the proximal and distalapproximation shafts, wherein rotation of the proximal and distalapproximation shafts effects movement of the first jaw in relation tothe second jaw between the clamped and unclamped positions.

In another aspect of the disclosure a tool assembly includes a first jawand a second jaw movable in relation to the each other from an unclampedposition to a clamped position. The first jaw is secured to the secondjaw by distal and proximal approximation shafts. The distal and proximalapproximation shafts are configured to effect parallel closure of thefirst and second jaws of the tool assembly. In the unclamped position,the distal approximation shaft is secured to a distal portion of thefirst jaw and a distal portion of the second jaw to secure the distalportion of the first jaw of the tool assembly to the distal portion ofsecond jaw of the tool assembly, and the proximal approximation shaft issecured to a proximal portion of the first jaw and a proximal portion ofthe second jaw to secure the proximal portion of the first jaw to theproximal portion of the second jaw.

In embodiments, the first jaw supports an anvil and the second jawsupports a cartridge assembly.

In some embodiments, the cartridge assembly includes an anvil drivescrew that is operably engaged with the distal and proximalapproximation shafts and is actuable to effect parallel closure of thejaws of the tool assembly.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the presently disclosed elongate tool assembly inassociation with a surgical stapling device are described herein belowwith reference to the drawings, wherein:

FIG. 1 is a side perspective view of one embodiment of the presentlydisclosed surgical stapling device with the tool assembly in a clampedposition;

FIG. 2 is a perspective view of a proximal end of an adaptor assembly ofthe surgical stapling device shown in FIG. 1 and a distal end of theactuator of the surgical stapling device shown in FIG. 1 with partsseparated illustrating an interface between the adaptor assembly and theactuator;

FIG. 3 is an enlarged, side perspective view of the tool assembly of thesurgical stapling device shown in FIG. 1 with the tool assembly in theunclamped position;

FIG. 4 is a cross-sectional view taken along the longitudinal axis ofthe tool assembly shown in FIG. 3 in the unclamped position;

FIG. 5 is a cross-sectional view taken along section line 5-5 of FIG. 4;

FIG. 6 is a cross-sectional view taken along section line 6-6 of FIG. 5with the tool assembly in an unclamped position;

FIG. 7 is a cross-sectional view taken along the longitudinal axis ofthe tool assembly shown in FIG. 6 in the clamped position;

FIG. 8 is a cross-sectional view taken along section line 8-8 of FIG. 7;and

FIG. 9 is a top view of the tool assembly of the surgical staplingdevice shown in FIG. 1 positioned about a body organ;

DETAILED DESCRIPTION OF EMBODIMENTS

The presently disclosed surgical stapling device including an elongatedtool assembly will now be described in detail with reference to thedrawings in which like reference numerals designate identical orcorresponding elements in each of the several views. In thisdescription, the term “proximal” is used generally to refer to thatportion of the device that is closer to a clinician, while the term“distal” is used generally to refer to that portion of the device thatis farther from the clinician. In addition, the term “clinician” is usedgenerally to refer to medical personnel including doctors, nurses, andsupport personnel. Further, the term “parallel closure” of a toolassembly is used herein generally to refer to approximation of first andsecond jaws of the tool assembly with planes defined by tissue contactsurfaces of the first and second jaws in a substantially parallelorientation, i.e., planes that together define an angle of less thanabout 10 degrees.

The presently disclosed surgical stapling device includes an actuator,an adaptor assembly extending distally from the actuator, and anelongated tool assembly that includes spaced jaws positioned to receivea body organ between proximal and distal ends of the jaws. Inembodiments, the tool assembly has a length of about 6 cm to about 34cm. The length of the tool assembly is selected to be suitable for aparticular surgical procedure. For example, in surgical proceduresincluding gastric sleeve procedures, the tool assembly may have a lengthof from about 27 cm to about 34 cm. In surgical procedures such aslobectomy procedures, the tool assembly may have a length of about 8 cmto about 10 cm. In addition, for other procedures such as hysterectomy,nephrectomy and colectomy procedures, the tool assembly may have alength of about 6 cm to about 8 cm.

In some embodiments, the tool assembly has a curved configuration, e.g.,banana-shaped, although other configurations, including linear, areenvisioned. To prevent outward deflection of the jaws of the toolassembly during clamping and firing of the elongated tool assembly,proximal and distal ends of the jaws are secured together withapproximation members. The approximation members are positioned toeffect parallel closure of the jaws of the tool assembly. By providing atool assembly that is dimensioned to transect a body organ in a singleactuation of the tool assembly, the time required to perform a surgicalprocedure and the experience level of the clinician required to performthe surgical procedure are lessened.

Referring to FIGS. 1 and 2, the presently disclosed surgical staplingdevice, shown generally as 10, includes an actuator 12, an adaptorassembly 14 extending distally from the actuator 12, and a tool assembly16 (FIG. 1) supported on a distal portion of the adaptor assembly 14.The tool assembly 16 may form part of a reload assembly 17 that isreleasably coupled to a distal portion of the adaptor assembly 14.Alternately, the tool assembly 16 may be secured directly to the distalportion of the adaptor assembly 14. In embodiments, the stapling device10 is a powered, handheld electromechanical stapling device and theactuator 12 includes a housing 18 that supports a battery (not shown)and a plurality of actuation buttons 20. The adaptor assembly 14 isreleasably coupled to the actuator 12 and includes a plurality of drivenshafts 22 (FIG. 2) that communicate with drive shafts 24 of the actuator12 to actuate various functions of the tool assembly 16 includingapproximation, articulation, and firing. The actuation buttons 20 areoperable to actuate the tool assembly 16. U.S. Patent Publication No.2015/0157321 discloses an electromechanical surgical stapling deviceincluding an actuator and adaptor assembly suitable for use with thepresently disclosed stapling device and is incorporated herein byreference in its entirety. Alternately, it is envisioned that the toolassembly 16 of the stapling device 10 may be incorporated into amanually powered stapling device or, in the alternative, be configuredto be used in association with a robotically driven system.

Referring to FIGS. 3-5, the tool assembly 16 includes first and secondjaws 30, 32. In embodiments, the first and second jaws 30, 32 are curvedalong their lengths and define a banana-like shape. In some embodiments,the first and second jaws 30, 32 have a radius of curvature of fromabout 15 cm to about 35 cm. However, it is envisioned that the size andcurvature of the tool assembly 16 be selected to be suitable for aparticular surgical procedure as discussed in further detail below. Thefirst jaw 30 is supported in relation to the second jaw 32 for movementbetween an unclamped position (FIG. 3) and a clamped position (FIG. 6).In embodiments, the first jaw 30 is supported in relation to the secondjaw 32 for parallel closure.

In embodiments, the first jaw 30 supports an anvil 34 that defines afirst tissue contacting surface 36 and the second jaw 32 supports acartridge assembly 38 that defines a second tissue contacting surface40. The cartridge assembly 38 includes a staple cartridge 42 thatdefines a plurality of staple retention slots 44 and a flexible stapledrive member 46 (FIG. 4) that supports an actuation sled 48 and a knifebar 50 that is secured to the actuation sled 48. The staple drive member46 is engaged with one of the driven shafts 22 (FIG. 2) of the actuator12 such that actuation of the staple drive member 46 effects translationof the actuation sled 48 and knife bar 50 through the tool assembly 16.In embodiments, the staple drive member 46 includes a threaded driveshaft 46 a and the actuation sled 48 defines a threaded bore 48 a (FIG.4) that receives the threaded drive shaft 46 a such that rotation of thethreaded drive shaft 46 a effects translation of the actuation sled 48and knife bar 50 through the tool assembly 16. The threaded drive shaft46 a is supported between distal and proximal bearing members 54, 56.Each of the staple retention slots 44 receives a staple (not shown) anda pusher (not shown) as is known in the art. The actuation sled 48 andthe knife bar 50 are movable through the tool assembly 16 tosequentially eject the staples (not shown) from the staple retentionslots 44 of the staple cartridge 42 and transect tissue.

The cartridge assembly 38 also includes a flexible jaw drive member 60(FIG. 4) and spaced distal and proximal approximation shafts 62 a and 62b, respectively. The jaw drive member 60 is positioned to engage theapproximation shafts 62 a and 62 b and has a distal portion supported onthe distal bearing member 54 and a proximal portion supported on theproximal bearing member 56. The distal and proximal approximation shafts62 a and 62 b are supported in orthogonal relation to the jaw drivemember 60 at each end of the tool assembly 16. In embodiments, thecartridge assembly 38 includes two distal and two proximal threadedapproximation shafts 62 a and 62 b (FIGS. 5 and 8). Alternately, the useof a single distal and proximal approximation shaft 62 a is envisioned.Each of the approximation shafts 62 a and 62 b has a first end that isrotatably supported but axially fixed in relation to one of the jaws,and a second end that is received within a threaded bore 66 (FIG. 5) ofthe other jaw. For example, the approximation shafts 62 a and 62 b mayhave a first end rotatably supported but axially fixed to the first jaw30 and a second end that is received in a threaded bore 66 (FIG. 5) ofthe second jaw 32. Alternately, the second jaw 32 may support theapproximation shafts 62 a and 62 b and the first jaw 30 may include thethreaded bore 66.

Referring to FIGS. 6-8, when the jaw drive member 60 is actuated, theapproximation shafts 62 a and 62 b are rotated to move the first jaw 30in relation to the second jaw 32 to move the tissue contacting surfaces36 and 40 of the first and second jaws 30 and 32, respectively, inrelation to each other between spaced (FIGS. 4 and 5) and approximated(FIGS. 7 and 8) positions. When this occurs, tissue positioned betweenthe jaws 30, 32 is clamped between the jaws 30, 32. Once the tissue isproperly clamped between the jaws 30, 32, the staple drive member 46 canbe actuated via the actuator 12 to advance the actuation sled 48 andknife bar 50 through the tool assembly 16 to staple and transect tissueclamped between the jaws 30, 32.

Referring also to FIG. 9, during a surgical procedure, such as a gastricsleeve procedure, a surgical stapling device 10 (FIG. 1) having anappropriately sized tool assembly 16 is positioned adjacent to a bodyorgan, e.g., the stomach “S”. With the tool assembly 16 in the unclampedposition (FIG. 3), a portion of the stomach “S” is pulled with a grasperor the like (not shown) to a position between the jaws 30, 32 of thetool assembly 16. When the stomach “S” is properly positioned within thetool assembly 16 to apply an appropriate staple line to the stomach “S”,the jaw drive member 60 (FIG. 7) is actuated to move the jaws 30, 32 inthe direction indicated by arrow “A” in FIG. 8 from the unclampedposition (FIG. 3) to the clamped position (FIG. 6) to clamp the stomach“S”. Thereafter, the staple drive member 46 is actuated to advance theactuation sled 48 through the tool assembly 16 to staple and dissecttissue. It is noted that the actuation sled 48 may support the knife bar50. Alternately, the tool assembly 16 need not have a knife bar 50 suchthat advancement of the actuation sled 48 only applies staples to a bodyorgan to create a pouch within the body organ such as the stomach “S”.

Persons skilled in the art will understand that the devices and methodsspecifically described herein and illustrated in the accompanyingdrawings are non-limiting exemplary embodiments. It is envisioned thatthe elements and features illustrated or described in connection withone exemplary embodiment may be combined with the elements and featuresof another without departing from the scope of the present disclosure.As well, one skilled in the art will appreciate further features andadvantages of the disclosure based on the above-described embodiments.Accordingly, the disclosure is not to be limited by what has beenparticularly shown and described, except as indicated by the appendedclaims.

What is claimed is:
 1. A surgical stapling device comprising: anactuator including a housing defining a handle assembly; an adaptorassembly having a proximal portion releasably secured to the actuatorand a distal portion; and a tool assembly supported on the distalportion of the adaptor assembly, the tool assembly including a first jawand a second jaw, the first jaw being movable in relation to the secondjaw from an unclamped position to a clamped position, the first jawbeing secured to the second jaw by distal and proximal approximationshafts, wherein in the unclamped position, the distal approximationshaft is secured to a distal portion of the first jaw and a distalportion of the second jaw to secure the distal portion of the first jawof the tool assembly to the distal portion of second jaw of the toolassembly, and the proximal approximation shaft is secured to a proximalportion of the first jaw and a proximal portion of the second jaw tosecure the proximal portion of the first jaw to the proximal portion ofthe second jaw.
 2. The surgical stapling device of claim 1, wherein thefirst jaw supports an anvil and the second jaw supports a cartridgeassembly.
 3. The surgical stapling device of claim 2, wherein thecartridge assembly includes a staple cartridge having a plurality ofstaples.
 4. The surgical stapling device of claim 3, wherein thecartridge assembly includes an anvil drive screw, the anvil drive screwbeing operably engaged with the distal and proximal approximation shaftsand actuable via the actuator to effect parallel closure of the jaws ofthe tool assembly.
 5. The surgical stapling device of claim 4, whereinthe cartridge assembly includes a sled that is supported within thestaple cartridge and movable from a retracted position to an advancedposition to eject the plurality of staples from the staple cartridge. 6.The surgical stapling device of claim 5, wherein the cartridge assemblyincludes a sled drive screw, the sled drive screw being operably engagedwith the sled to move the sled from the retracted position to theadvanced position.
 7. The surgical stapling device of claim 1, whereinthe tool assembly defines a radius of curvature of between 15 cm and 35cm.
 8. The surgical stapling device of claim 7, wherein the toolassembly has a length of between 27 cm and 34 cm.
 9. The surgicalstapling device of claim 7, wherein the tool assembly has a length ofbetween 8 cm and 10 cm.
 10. The surgical stapling device of claim 7,wherein the tool assembly has a length of between 6 cm and 8 cm.
 11. Thesurgical stapling device of claim 1, wherein the proximal approximationshaft includes a pair of proximal approximation shafts and the distalapproximation shaft includes a pair of distal approximation shafts. 12.The surgical stapling device of claim 1, wherein each of the proximaland distal approximation shafts includes a threaded shaft rotatablysupported on the first jaw and axially fixed to the first jaw, thesecond jaw defining a threaded bore that receives each of the proximaland distal approximation shafts, wherein rotation of the proximal anddistal approximation shafts effects movement of the first jaw inrelation to the second jaw between the clamped and unclamped positions.13. The surgical stapling device of claim 1, wherein the distal andproximal approximation shafts are configured to effect parallel closureof the first and second jaws of the tool assembly.
 14. A tool assemblycomprising: a first jaw and a second jaw, the first jaw being movable inrelation to the second jaw from an unclamped position to a clampedposition, the first jaw being secured to the second jaw by distal andproximal approximation shafts, the distal and proximal approximationshafts being configured to effect parallel closure of the first andsecond jaws of the tool assembly, wherein in the unclamped position, thedistal approximation shaft is secured to a distal portion of the firstjaw and a distal portion of the second jaw to secure the distal portionof the first jaw of the tool assembly to the distal portion of secondjaw of the tool assembly, and the proximal approximation shaft issecured to a proximal portion of the first jaw and a proximal portion ofthe second jaw to secure the proximal portion of the first jaw to theproximal end of the second jaw.
 15. The tool assembly of claim 14,wherein the first jaw supports an anvil and the second jaw supports acartridge assembly.
 16. The tool assembly of claim 15, wherein thecartridge assembly includes an anvil drive screw, the anvil drive screwbeing operably engaged with the distal and proximal approximation shaftsand actuable to effect parallel closure of the jaws of the toolassembly.
 17. The tool assembly of claim 14, wherein the tool assemblyhas a length of between 27 cm and 34 cm.
 18. The tool assembly of claim14, wherein the tool assembly has a length of between 8 cm and 10 cm.19. The tool assembly of claim 14, wherein the tool assembly has alength of between 6 cm and 8 cm.
 20. The tool assembly of claim 14,wherein the tool assembly defines a radius of curvature of between 15 cmand 35 cm.